Assessment of the effect of jadwar capsule (delphinium denudatum) on clinical manifestation of knee Osteoartheritis versus Placebo : A double blind randomized controlled clinical trial.
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General information
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94
94
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2019-06-15, 1398/03/25
2019-06-15 00:00:00
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2019-12-16, 1398/09/25
2019-12-16 00:00:00
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2020-01-15, 1398/10/25
2020-01-15 00:00:00
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Updating the start and end date of patient recruitment has been accomplished
Updating the start and end date of patient recruitment has been accomplished
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به روز رسانی تاریخ شروع و پایان بیمارگیری تحقق یافته
به روز رسانی تاریخ شروع و پایان بیمارگیری تحقق یافته
Protocol summary
Study aim
Determination of the effects of Jadwar capsul on clinical manifestations of knee Osteoarthritis versus placebo
Design
Randomized controlled clinical trial with a parallel group design of 94 patient.phase 3.
Settings and conduct
Study will be performed in Tabriz Shohada hospital.Participants will be placed on intervention and control groups according block disign randomization method, after obtaining the informed consent and they will receive the drug or placebo for four weeks and thay will be under observation through this period.The study will be double-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 40 to 70 ; Mild to moderate knee Ostoarthritis patients according to Kellegren-Lawrence (K-L) grading scale ; Minimum annoying pain (at least 4 ) in last week before random allocation, according to VAS scale ; Pain at least in one knee in last 3 month ago. Exclusion criteria: Allergy to jadwar capsul ; Secondary osteoarthritis ; Joint transplantation ; Oral or topical use of steroids ; Pregnancy & lactation ; Addiction ; Radiculopathy or Neuropathy ; Surgery ; Trauma
Intervention groups
The intervention group received 500 mg jadwar capsules twice a day for four weeks each day.The control group received placebo capsules twice a day for four weeks. Pelacebo and jadwar Capsules are Produced in the shafanegar nazary pharmaceutical company.
Main outcome variables
1. Knee pain score according to Visual Analogue Scale and West Ontario McMaster universities questionaire 2. Daily activity score according to Visual Analogue Scale and West Ontario Mc master universities questionaire
General information
Reason for update
Updating the start and end date of patient recruitment has been accomplished
Acronym
IRCT registration information
IRCT registration number:IRCT20181218042037N1
Registration date:2019-06-13, 1398/03/23
Registration timing:prospective
Last update:2020-06-12, 1399/03/23
Update count:1
Registration date
2019-06-13, 1398/03/23
Registrant information
Name
Rogaiyeh Baghervandnavid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3382 6501
Email address
baghervandnavid@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-15, 1398/03/25
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
2019-06-15, 1398/03/25
Actual recruitment end date
2019-12-16, 1398/09/25
Trial completion date
2020-01-15, 1398/10/25
Scientific title
Assessment of the effect of jadwar capsule (delphinium denudatum) on clinical manifestation of knee Osteoartheritis versus Placebo : A double blind randomized controlled clinical trial.
Public title
Assessment of jadwar capsule on clinical manifestation of knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to moderate knee Ostoarthritis patients according to Kellegren-Lawrence (K-L) grading scale
Pain at least in one knee in last 3 month ago
Minimum annoying pain (at least 4 ) before randomized selection according to VAS scale
Exclusion criteria:
Allergy to oral consumption of jadwar capsul.
Secondary Osteoarthritis as Rhuomatoid arthritis,Gout,Infectious arthritis,Metabolic arthritis,Traumatic arthritis.
Operative knee joint replacement .
Topical or systemic steroid use since 14 day before study .
Intraarticular steroid injection since 90 day before study .
Pregnancy and lactation period .
Alcohol and opioid addiction
Radiculopathy and Neuropathy .
History of any kind of knee operation and trauma
Utilization of other analgesic drugs since study period
History of renal failure or heart failure or hepatic failure
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
94
Actual sample size reached:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Block design randomization as individual by
Random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
participantِ
clinical care providerِ
researcher
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences
Street address
Tabriz University of Medical Sciences central building , Daneshgah Ave. , Tabriz
City
tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2019-03-12, 1397/12/21
Ethics committee reference number
IR.TBZMED.REC.1397.1054
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Score of knee pain intensity
Timepoint
Measuring the Score of knee pain intensity at the beginning of the study and 14 and 28 days after starting use of jadwar capsul.
Method of measurement
Visual Analogue Scale
2
Description
Daily activity Score
Timepoint
Measuring of Daily activity Score at the beginning of the study and 14 and 28 days after starting use of jadwar capsul.
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group participants receive 500 m/g of jadwar capsul in the morning and at night for 4 weeks. jadwar Capsules are Produced in the shafanegar nazary pharmaceutical company.
Category
Treatment - Drugs
2
Description
Control group: In this group participants receive 2 placebo capsules containing starch in the morning and at night for 4 weeks. pelacebo Capsules will be Produced in the shefanegar nazary pharmaceutical company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada hospital
Full name of responsible person
rogayeh baghervandnavid
Street address
Shohada hospital , Golshahr St., El-goli Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614754
Phone
+98 41 3389 3336
Email
baghervandnavid@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Golghasht Ave., No 2 Central Building of tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3336 9798
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Rogayeh Baghervandnavid
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 3, Alley 41, Goldasht St., Zafaranieh Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166773183
Phone
+98 41 3382 6501
Email
baghervandnavid@tbzmwd.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Rogaiyeh Baghervandnavid
Position
phd student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 3, Alley 41, Goldasht St., Zafaranieh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166773183
Phone
+98 41 3382 6501
Email
baghervandnavid@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Rogayeh Baghervandnavid
Position
phd student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
afra biulding 41dahmetry goldasht zafaranyih
City
Tabriz
Province
East Azarbaijan
Postal code
5166773183
Phone
+98 41 3382 6501
Email
baghervandnavid@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The whole potential data after being unidentifiable is shareable
When the data will become available and for how long
Start the access period 4 months after printing the article
To whom data/document is available
Researchers working in academic, scientific and industrial institutions